Extractable & Leachable Studies

Regulators are concerned with substances migrating from different materials (polymers, metals, glass etc.) which patients may be exposed to through many different routes of administration, such as:

Analytical Techniques for Extractables and Leachables Studies

Numerous analytical techniques are used for E&L studies because no single analytical technique can detect them all.

In order to obtain successful regulatory approval for new drug applications, packaging interactions with the drug product should be evaluated to ensure product safety.

The degree of interaction between the drug product and the primary packaging is dependent on the product type, as is the risk to the patient. Chromak Research follow best practice guidelines, such as those provided by the PQRI for OINDP and USP chapters 1663 and 1664.